BAAT Medical

BAAT Medical offers end-to-end solutions for medical device innovation, from strategy and funding to development, manufacturing, and regulatory compliance. They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.

BAAT Medical is a comprehensive partner for medical device innovators, providing end-to-end solutions to bring cutting-edge technologies to market. They cater to a range of medical devices, from Class I to Class III, including instruments, wearables, (smart) implants, custom-made products, and medicinal combination devices. Their expertise spans the entire product lifecycle, starting with strategic evaluation of the device idea, market research, and business case development. They assist in securing funding, guiding startups and established companies through the financial landscape. The development phase is handled with a focus on turning concepts into tangible, market-ready products, ensuring innovative design and regulatory compliance. BAAT Medical also excels in manufacturing, scaling production to meet market demands while maintaining quality and readiness for approval. Furthermore, they offer robust regulatory affairs support, including navigating complex regulations like the MDR, and act as the Legal Manufacturer for custom-made devices, ensuring patient safety and compliance. Their proven process minimizes risks and optimizes for successful market entry or exits, helping clients achieve real-world impact in medical device innovation.

About

**Who they are**
BAAT Medical is an end-to-end solutions provider for medical device innovation, based in The Netherlands. They specialize in guiding medical device concepts from initial strategy and funding through development, manufacturing, and regulatory compliance.

**Expertise & scope**
* End-to-end support for medical device innovation.
* Strategy development, including market research, market entry, business case development, and industry connections.
* Funding support to secure capital for device development and market entry, with expertise in early-stage startup funding.
* Product development services.
* Manufacturing and scaling solutions.
* Regulatory compliance, including expertise in MDR compliance for 3D-printed devices, acting as the Legal Manufacturer for custom-made surgical guides.
* Support for Class I-III devices, including implants and wearables.
* Facilitation of US Market access.

**Reputation / proof points**
* Acts as the Legal Manufacturer for MDR-compliant 3D-printed devices, issuing Statement Annex XIII.
* Specializes in custom-made 3D models and patient-specific devices.
* Partnership with 3DMM for MDR-compliant 3D printing solutions.

Additional information

BAAT Medical emphasizes a comprehensive approach to medical device commercialization. Their regulatory compliance services are particularly noted for addressing the complexities of 3D-printed medical devices under the MDR. By acting as the Legal Manufacturer for specific custom-made products, they provide a clear compliance pathway, issuing necessary documentation like Statement Annex XIII. This service is designed to clarify accountability, especially in scenarios involving patient-specific surgical guides where responsibility for safety, biocompatibility, and cleanliness is critical. They support clients in navigating the regulatory landscape to ensure efficient market entry.

Key Highlights

  • Acts as the Legal Manufacturer for MDR-compliant 3D-printed custom-made devices. Source
    “BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance.”
  • Provides end-to-end solutions from strategy and funding to development, manufacturing, and regulatory compliance. Source
    “From crafting your strategy, developing your product, streamlining manufacturing and delivering your product everywhere while ensuring ongoing compliance.”
  • Specializes in Class I-III devices, including implants and wearables. Source
    “They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.”
  • Offers support for US Market access. Source
    “US Market access”

Certifications & Trust Signals

  • Based in The Netherlands, serving the EU market. Source
    “F. Hazemeijerstraat 800 – Building A04 7555 RJ Hengelo The Netherlands”

Buyer Snapshot

Best for
  • Medical device innovators seeking end-to-end support.
  • Startups requiring assistance with strategy, funding, and regulatory compliance.
  • Companies needing MDR compliance solutions for 3D-printed devices.
How engagement typically works
  • Collaborative, acting as a partner throughout the product lifecycle.
  • Providing specialized regulatory roles, such as Legal Manufacturer.
Typical deliverables
  • Regulatory strategy and compliance documentation (e.g., Technical Files, Statement Annex XIII).
  • Funding strategy and support.
  • Market entry plans.
  • Development and manufacturing roadmaps.
Good to know
  • Best when clients require comprehensive support from concept to market.
  • Particularly relevant for custom-made or 3D-printed medical devices requiring MDR compliance.
HQ: Hengelo, Netherlands
Languages: English, Dutch
Timezones: Europe/Amsterdam
Status: listed

Services & Capabilities

PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes

Jurisdictions: EU
Countries: US, EU
Industries: Medical devices, IVD, SaMD, Manufacturing
Portfolio: 26-100
Onboarding time: 3–14 days
Pricing model: Onboarding + annual retainer
Starting from: EUR 3,200
Included services: PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC: Yes
Device Classes Supported: Class I, Class IIa
PRRC Qualification Summary: BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance. Hospitals retain responsibility for clinical use, but BAAT shoulders the accountability as the Legal Manufacturer, ending the back-and-forth confusion. This MDR-approved route designates BAAT as the responsible party, safeguarding patient safety and ensuring regulatory compliance in healthcare. The question of “Who is the Legal Manufacturer?” is now solved with BAAT Medical as the Legal Manufacturer and 3DMM as the production expert, this partnership delivers MDR-compliant custom-made devices with transparency and trust.

Additional prrc_service Details

Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Involves evaluating the value proposition, performing a Business Scan, and defining strategy, development, manufacturing, and compliance pathways.
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
true
Supports IVDR
No
PRRC Qualification Summary
Acts as Legal Manufacturer, validates processes, creates technical files, issues Statement Annex XIII for MDR compliance.
Regulatory Experience
Expertise in MDR compliance for 3D-printed devices.
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